Premier Research is hiring for 2 Site Solutions roles as part of its India Operations team: Site Solutions Executive and Site Solutions Executive Level 1.

Both positions support clinical trial activities at sites, including protocol compliance, clinical trial documentation, patient scheduling, data entry, ethics committee submissions, clinical supplies, site performance, and communication between investigators and sponsors/CROs.

Job Details

Positions

1. Site Solutions Executive

Job Requisition ID: R6983

The Site Solutions Executive coordinates and facilitates clinical trial activities at sites while supporting the Principal Investigator and site study team in meeting sponsor, regulatory, protocol, and GCP requirements.

2. Site Solutions Executive Level 1

Job Requisition ID: R6965

The Site Solutions Executive Level 1 performs clinical trial site activities including documentation, data entry, patient scheduling, ethics committee coordination, clinical supply management, site performance reporting, and support for audits and inspections.

Key Responsibilities

Responsibilities across the two roles include:

• Coordinate clinical trial activities at the site in compliance with protocols, GCP guidelines, and local regulations.
• Support Principal Investigators and site study teams.
• Review site processes, identify gaps, and support process implementation.
• Perform timely CRF/eCRF data entry in consultation with the PI/Investigator.
• Maintain clinical trial documentation, including the Trial Master File.
• Support site initiation, monitoring, close-out, QA, sponsor visits, inspections, and patient visits.
• Report site performance metrics at predetermined intervals.
• Coordinate submissions to ethics committees for protocols, adverse events, and periodic study reports.
• Schedule patient investigations and assessments as directed by the PI.
• Ensure availability, storage, accountability, and documentation of investigational products, lab kits, and other clinical trial supplies.
• Coordinate laboratory sample pick-ups and reporting.
• Assist with source document transcription and review.
• Support timely resolution of data queries.
• Coordinate patient scheduling, screening, and enrolment.
• Maintain contact with site monitors regarding enrolment, visits, dosing, and dispensing.
• Facilitate communication between investigators and sponsors/CROs.
• Support patient-awareness and training events.
• Support feasibility and epidemiological data collection.
• Create databases of potential patients eligible for study enrolment according to the protocol.
• Identify site challenges and support mitigation planning.
• Complete required training modules and SOP training.
• Notify sponsor/CRO representatives about external audits and regulatory inspections.
• Collaborate with the PI on audit findings and approved recommendations.
• Escalate systemic non-compliance or misconduct to the manager.
• Direct site feasibilities to the feasibility team at Clinical Services.

Eligibility & Qualifications

Candidates should have:

• A Bachelor’s or Master’s degree in clinical, biological, or mathematical sciences or related fields; or
• A medical or dental degree; or
• A nursing qualification.
• Exceptions to these educational requirements require a minimum of 4 years of experience working at clinical research sites.
• Good oral and written communication skills in English and at least one local Indian language.

Required Skills

• Clinical Trial Coordination
• GCP Compliance
• Clinical Research Documentation
• CRF/eCRF Data Entry
• Trial Master File Management
• Ethics Committee Coordination
• Patient Screening and Enrolment
• Clinical Trial Supplies Management
• Site Performance Reporting
• Data Query Resolution
• Audit and Inspection Support
• Communication and Interpersonal Skills
• Coordination and Organization
• Problem-Solving and Analytical Skills
• Attention to Detail
• Data Accuracy
• Patient Safety and Patient Rights
• Computer and Office Communication Tools

Application Details